Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery

NCT ID: NCT00448643

Last Updated: 2016-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2011-03-31

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also make tumor cells more sensitive to cisplatin. Giving radiation therapy together with cisplatin after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal radiation therapy when given together with cisplatin in treating patients with stage III or stage IV endometrial cancer that has been removed by surgery.

Detailed Description

OBJECTIVES:

• Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when administered with cisplatin in patients with optimally debulked stage III or IV carcinoma of the endometrium.

OUTLINE: This is a dose-escalation study of whole-abdominal radiotherapy (WAR).

Patients receive 3 courses of standard chemotherapy comprising carboplatin IV and paclitaxel IV. Beginning within 6 weeks after completion of standard chemotherapy, patients receive cisplatin IV over 30-60 minutes and undergo a single fraction of WAR on day 1. Treatment with cisplatin and WAR repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo standard vaginal brachytherapy beginning no earlier than the last course of standard chemotherapy or no later than 1 week before the start of cisplatin and WAR.

Cohorts of 3-6 patients receive escalating doses of WAR until the recommended phase II dose (RPTD) is determined. The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the RPTD.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions

Endometrial Cancer

Keywords

endometrial adenocarcinoma; endometrial clear cell carcinoma; endometrial papillary carcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whole-Abdominal Radiation Therapy and Chemotherapy

Group Type: EXPERIMENTAL

Vaginal Brachytherapy

Intervention Type: RADIATION

High-Dose Rate \[HDR\] or Low-Dose Rate \[LDR\], no earlier than during last cycle of Carboplatin/Taxol chemotherapy; or no later than 1 week before cisplation and WAR therapy

Cisplatin

Intervention Type: DRUG

Weekly at 40 mg/m2 (maximum of 70 mg) for 6 weeks, start no later than 6 weeks from last cycle of standard of care carboplatin and taxol chemotherapy

Whole Abdominal Radiation [WAR] Therapy

Intervention Type: RADIATION

Whole Abdominal Radiation Therapy, Dose Escalated \[2-Levels\]; 6 -8 hours after administration of Cisplatin chemotherapy

Interventions

Vaginal Brachytherapy

High-Dose Rate \[HDR\] or Low-Dose Rate \[LDR\], no earlier than during last cycle of Carboplatin/Taxol chemotherapy; or no later than 1 week before cisplation and WAR therapy

Intervention Type: RADIATION

Cisplatin

Weekly at 40 mg/m2 (maximum of 70 mg) for 6 weeks, start no later than 6 weeks from last cycle of standard of care carboplatin and taxol chemotherapy

Intervention Type: DRUG

Whole Abdominal Radiation [WAR] Therapy

Whole Abdominal Radiation Therapy, Dose Escalated \[2-Levels\]; 6 -8 hours after administration of Cisplatin chemotherapy

Intervention Type: RADIATION

Other Intervention Names

WAR

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of endometrial cancer, including any of the following cellular types:

• Papillary serous carcinoma
• Clear cell carcinoma
• Adenocarcinoma
• Stage III or IV disease

• No evidence of extra-abdominal extension of disease (e.g., groin nodes, lung, or supraclavicular nodes)
• Has undergone total-abdominal hysterectomy, surgical removal of any present fallopian tube and ovary, and resection of any palpable lymph nodes in the pelvis and para-aortic region (or surgical sampling of these nodal regions if no palpable nodes were present) within the past 6 weeks

• Peritoneal washings must have been collected for cytological evaluation
• Must have ≤ 1 cm residual disease after surgery

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Life expectancy ≥ 6 months
• WBC ≥ 3,000/mm^3
• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Creatinine < 2.0 mg/dL
• Bilirubin < 1.5 times upper limit of normal (ULN)
• Lactate dehydrogenase < 3 times ULN
• Gamma glutamyl transferase < 3 times ULN
• SGPT and SGOT < 3 times ULN
• Alkaline phosphatase < 3 times ULN
• No other malignant tumor within the past 5 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior radiotherapy to the whole abdomen and/or pelvis/vagina
• No systemic chemotherapy within the past 5 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron H. Wolfson, MD

Role: STUDY_CHAIR

University of Miami Sylvester Comprehensive Cancer Center

Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

SCCC-2001064

Identifier Type: -

Identifier Source: secondary_id

WIRB-20050721

Identifier Type: -

Identifier Source: secondary_id

20020138

Identifier Type: -

Identifier Source: org_study_id